Sepsis study comparing three treatment methods shows same survival rate

March 18, 2014

Survival of patients with septic shock was the same regardless of whether they received treatment based on specific protocols or the usual high-level standard of care, according to a five-year clinical study. The large-scale randomized trial, named ProCESS for Protocolized Care for Early Septic Shock, was done in 31 academic hospital emergency departments across the country and was funded by the National Institute of General Medical Sciences (NIGMS), a component of the National Institutes of Health.

The results of the trial, led by Derek C. Angus, M.D., M.P.H., and Donald M. Yealy, M.D., of the University of Pittsburgh, appear online on March 18, 2014, in the New England Journal of Medicine.

"ProCESS set out to determine whether a specific protocol would increase the survival rates of people with . What it showed is that regardless of the method used, patient survival was essentially the same in all three treatment groups, indicating that sepsis patients in these clinical settings were receiving effective care," said Sarah Dunsmore, Ph.D., who managed the ProCESS trial for NIGMS.

Sepsis is a body-wide inflammation, usually triggered by an infection. It can lead to a dangerous drop in blood pressure, called septic shock, that starves tissues of oxygen and chokes out major organs: lungs, kidneys, liver, intestines, heart. It remains frustratingly hard to identify, predict, diagnose and treat.

According to the Centers for Disease Control and Prevention, sepsis affects more than 800,000 Americans annually and is the ninth leading cause of disease-related deaths. The Agency for Healthcare Research and Quality lists sepsis as the most expensive condition treated in U.S. hospitals, costing more than $20 billion in 2011.

The ProCESS trial set out to test three approaches to sepsis care. It enrolled 1,341 patients randomly divided into these groups:

Group 1: Early Goal-Directed Therapy

Doctors inserted a central venous catheter—a long, thin tube placed close to a patient's heart—to continuously monitor blood pressure and blood oxygen levels. For the first six hours of care, doctors kept these levels within tightly specified ranges using intravenous fluids, cardiovascular drugs and blood transfusions. This protocol was based on a 2001 study in an urban emergency department that noted a striking increase in sepsis survival using this approach.

Group 2: Protocolized Standard Care

This alternative tested a less invasive protocol that did not require central venous catheter insertion. Doctors used standard bedside measures like blood pressure (taken using an arm cuff), heart rate and clinical judgment to evaluate patient status and guide treatment decisions. Doctors kept patient and fluid levels within specified ranges for the first six hours of care.

Group 3: Standard Care

Patients received the same high level of care they would typically get in an academic hospital emergency department. Their doctors did not follow specific guidelines or protocols associated with the study.

After using an array of statistical analysis tools, the ProCESS investigators concluded that the three treatment arms produced results that were essentially indistinguishable for a range of patient outcomes. These outcomes included survival at 60 days, 90 days and one year; heart and lung function; length of hospital stay; and a standardized measurement of health status at discharge.

"ProCESS helps resolve a long-standing clinical debate about how best to manage sepsis patients, particularly during the critical first few hours of treatment," said Yealy.

"The good news from this study is that, as long as sepsis is recognized promptly and patients are adequately treated with fluid and antibiotics, there is not a mandated need for more invasive care in all patients," added Angus.

In addition to clarifying sepsis treatment options, ProCESS was a milestone for NIGMS.

"ProCESS was the first large-scale clinical trial to be supported by NIGMS, which primarily funds basic, non-disease-targeted research," said Dunsmore. "We hope that ProCESS and other NIGMS- and NIH-funded sepsis research efforts will help improve treatment, speed recovery and increase for patients."

Explore further: High volume of severe sepsis patients may result in better outcomes

Related Stories

High volume of severe sepsis patients may result in better outcomes

January 17, 2014
A recent study led by Boston University School of Medicine (BUSM) shows that "practice may make perfect" when it comes to caring for patients with severe sepsis. The study showed that patients admitted to academic medical ...

Research identifies potential new treatment for sepsis

November 14, 2013
Sepsis is the leading cause of in-hospital death and there is no specific treatment for it. Now, research led by Dr. Qingping Feng of Western University (London, Canada) suggests a protein called recombinant human annexin ...

Fast method to detect sepsis derived from missile launch technology

February 25, 2014
Using analytical technology developed to detect launched missiles, Lockheed Martin [NYSE: LMT] has discovered a way to identify sepsis, a potentially fatal blood condition, between 14 to 16 hours earlier than physicians currently ...

Researchers discover potential novel treatment against septic shock

February 7, 2014
Septic shock is caused by excessive and systemic reaction of the entire body against infectious agents, in most cases of bacterial origin. The number of deaths by septic shock in intensive care units is very high and is still ...

Study shows decrease in sepsis mortality rates

November 13, 2013
A recent study from Boston University School of Medicine (BUSM) and Boston Medical Center (BMC) shows a significant decrease in severe sepsis mortality rates over the past 20 years. Looking at data from patients with severe ...

Not all 'surviving sepsis' intervention recs are adopted

January 21, 2013
(HealthDay)—Not all nursing interventions recommended in the Surviving Sepsis Campaign (SSC) are actually implemented in emergency departments, according to a review published in the January issue of the Journal of Emergency ...

Recommended for you

Want to win at sports? Take a cue from these mighty mice

July 20, 2017
As student athletes hit training fields this summer to gain the competitive edge, a new study shows how the experiences of a tiny mouse can put them on the path to winning.

'Smart' robot technology could give stroke rehab a boost

July 19, 2017
Scientists say they have developed a "smart" robotic harness that might make it easier for people to learn to walk again after a stroke or spinal cord injury.

Engineered liver tissue expands after transplant

July 19, 2017
Many diseases, including cirrhosis and hepatitis, can lead to liver failure. More than 17,000 Americans suffering from these diseases are now waiting for liver transplants, but significantly fewer livers are available.

Lunatic Fringe gene plays key role in the renewable brain

July 19, 2017
The discovery that the brain can generate new cells - about 700 new neurons each day - has triggered investigations to uncover how this process is regulated. Researchers at Baylor College of Medicine and Jan and Dan Duncan ...

New animal models for hepatitis C could pave the way for a vaccine

July 19, 2017
They say that an ounce of prevention is worth a pound of cure. In the case of hepatitis C—a disease that affects nearly 71 million people worldwide, causing cirrhosis and liver cancer if left untreated—it might be worth ...

Omega-3 fatty acids fight inflammation via cannabinoids

July 18, 2017
Chemical compounds called cannabinoids are found in marijuana and also are produced naturally in the body from omega-3 fatty acids. A well-known cannabinoid in marijuana, tetrahydrocannabinol, is responsible for some of its ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.